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OpenTrials
Completed

NCT Number: NCT02782585

Manual Therapy Techniques on Cervical Spine and Psychological Interaction

Manual therapy (MT) techniques applied over cervical region have over both local (neck) and distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological mechanisms are hypothesized to explain the underlying effects, with effects originating from peripheral mechanisms, spinal cord and supraspinal mechanisms.

There is also an increasing interest in the study of the role of psychological variables in the treatment success in neck pain. Psychological variables, like anxiety catastrophizing or kinesiophobia are related to poor prognosis in the development of pain outcomes and disability in neck pain, being the Fear-Avoidance Model of pain one of the most tested models in this field.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neck pain

Exclusion criteria

  • myelopathy
  • fracture
  • infection
  • dystonia
  • tumor
  • inflammatory disease
  • fibromyalgia
  • or osteoporosis

Treatment and study plan

Cervical Manipulation

Other

The therapist cradled the subject´s head with the other hand. Gentle ipsilateral side flexion and contralateral rotation to the targeted side were introduced until slight tension was perceived in the tissues at the contact point. The High velocity, low amplitude (HVLA) manipulation was directed upward and medially in the direction of the subject´s contralateral eye. The therapist monitored for cavitation or 'popping sound' accompanying the manipulations. If an audible popping sound was not heard during the first manipulative attempt, the procedure was repeated in the second time.

cervical lateral glide

Other

The upper limb of the right side of subjects was maintained in rest, with the arm along the trunk and the hand over the abdominal wall. The right hand of the treating therapist was positioned over scapula region, to depress the scapula while left hand cradled the occiput and neck above C5-C6 and left hand produced a passive lateral movement of the occipital and neck region.

cervical mobilisation

Other

The patients received a passive cervical mobilization that involved a grade III oscillatory unilateral posteroanterior mobilization to the right articular pillar of C5/C6 segment as described Maitland at a frequency of 2Hz. All the subjects were positioned in prone position as the protocol described by Sterling et al. for 3 sets of 2 minutes with 1 minute rest between sets.

Primary outcomes

  1. Change from Pressure Pain Thresholds (PPT) at 24 hours

    Time frame: 24 hours, 5 minutes after the treatment

    PPT will be assessed bilaterally over the C7 zygapophyseal joint, epicondyle region, and trapezious muscle by an assessor blinded to the subjects condition.

  2. Change from State-Trait Anxiety Inventory subscale (STAI-E) at 24 hours

    Time frame: 24 hours, 5 minutes after the treatment

    Will be used to measure anxiety status

Secondary outcomes

  1. Beck depression Inventory (BDI-II)

    Time frame: 24 hours, 5 minutes after the treatment

    Will be used to measure depression status

  2. Tampa Scale for Kinesiophobia

    Time frame: 24 hours, 5 minutes after the treatment

    Will be used to measure Kinesiophobia status

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Hypoalgesic Effects of Three Different Manual Therapy Techniques on Cervical Spine and Psychological Interaction: Randomized Clinical Trial

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 25, 2016
Registry last updated
May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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